A Phase 1 Open Label, Multicenter, Multiple Ascending Dose Trial Evaluating the Safety, Tolerability and Immunogenicity of Intramuscular Recombinant NY-ESO-1 Protein with GLA-SE Adjuvant in Patients with Unresectable or Metastatic Cancer Expressing NY-ESO-1 Cancer Antigen
Description: 

This is a Phase 1, open label, multicenter, multiple ascending dose trial of IDC-G305 administered by IM injection at Day 0, 21 and 42 in a 3+3 sequential dose escalation design. Patients will be screened for up to 14 days prior to dosing. Peripheral blood will be drawn for immunogenicity assays at baseline, then prior to each of the two subsequent injections, and four weeks after the third injection. If an eligibility criterion is considered to be borderline by the investigator, then it will be discussed with the sponsor medical monitor. Each of three dose level cohorts will be treated contingent upon absence of dose limiting toxicity (DLT) and acceptable safety data for the preceding cohort.

Study Number: 

PH 244813

Phase: 
I
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT02015416

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.